Valstar

INDICATIONS

VALSTAR (valrubicin) is indicated for intravesical therapy of BCG-refractory carcinomain
situ (CIS) of the urinary bladder in patients for whom immediate cystectomy
would be associated with unacceptable morbidity or mortality.

DOSAGE AND ADMINISTRATION

VALSTAR (valrubicin) is recommended at a dose of 800 mg administered intravesically once
a week for six weeks. Administration should be delayed at least two weeks after
transurethral resection and/or fulguration. For each instillation, four 5 mL
vials (200 mg valrubicin/5 mL vial) should be allowed to warm slowly to room
temperature, but should not be heated. Twenty milliliters of VALSTAR (valrubicin) should
then be withdrawn from the four vials and diluted with 55 mL 0.9% Sodium Chloride
Injection, USP providing 75 mL of a diluted VALSTAR (valrubicin) solution. A urethral catheter
should then be inserted into the patient's bladder under aseptic conditions,
the bladder drained, and the diluted 75 mL VALSTAR (valrubicin) solution instilled slowly
via gravity flow over a period of several minutes. The catheter should then
be withdrawn. The patient should retain the drug for two hours before voiding.
At the end of two hours, all patients should void. (Some patients will be unable
to retain the drug for the full two hours.) Patients should be instructed to
maintain adequate hydration following treatment.

Administration Precautions: As recommended with other cytotoxic agents,
caution should be exercised in handling and preparing the solution of VALSTAR (valrubicin) .
Contact toxicity, common and severe with other anthracyclines, is not typical
with VALSTAR (valrubicin) and, when observed, has been mild. Skin reactions may occur with
accidental exposure, and the use of gloves during dose preparation and administration
is recommended. Irritation of the eye has also been reported with accidental
exposure. If this happens, the eye should be flushed with water immediately
and thoroughly.

VALSTAR (valrubicin) sterile solution contains polyoxyl castor oil, which has been known
to cause leaching of di(2-ethylhexyl)phthalate (DEHP) a hepatotoxic plasticizer,
from polyvinyl chloride (PVC) bags and intravenous tubing. VALSTAR (valrubicin) solutions
should be prepared and stored in glass, polypropylene, or polyolefin containers
and tubing. It is recommended that non-DEHP containing administration sets,
such as those that are polyethylene-lined, be used.

Procedures for proper handling and disposal of anticancer drugs should be used.1-7
Spills should be cleaned up with undiluted chlorine bleach.

Preparation for Administration: VALSTAR (valrubicin) Sterile Solution for Intravesical
Instillation is a clear red solution. It should be visually inspected for particulate
matter and discoloration prior to administration. At temperatures below 4°C,
polyoxyl castor oil may begin to form a waxy precipitate. If this happens, the
vial should be warmed in the hand until the solution is clear. If particulate
matter is still seen, VALSTAR (valrubicin) should not be administered.

Stability: Unopened vials of VALSTAR (valrubicin) are stable until the date indicated
on the package when stored under refrigerated conditions at 2°-8°C (36°-46°F).
Vials should not be heated. VALSTAR (valrubicin) diluted in 0.9% Sodium Chloride Injection,
USP for administration is stable for 12 hours at temperatures up to 25°C
(77°F). Since compatibility data are not available, VALSTAR (valrubicin) should not be
mixed with other drugs.

Store vials under refrigeration at 2°-8°C (36°-46°F) in the
carton. DO NOT FREEZE.

For more information, call 1-888-282-5372.

REFERENCES

1.Recommendations for the Safe Handling of Parenteral Antineoplastic
Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents,
U.S. Government Printing Office, Washington, DC 20402.